Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name biopsy needle
510(k) Number K011075
Device Name EASYBELL
Applicant
BIOPSYBELL S.A.S.
131 HIGHWOOD DR.
SOUTH GLASTONBURY,  CT  06073
Applicant Contact LUCIO IMPROTA
Correspondent
BIOPSYBELL S.A.S.
131 HIGHWOOD DR.
SOUTH GLASTONBURY,  CT  06073
Correspondent Contact LUCIO IMPROTA
Regulation Number876.1075
Classification Product Code
FCG  
Date Received04/09/2001
Decision Date 06/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-